NCT05006001

Evaluation of Colchicine and Nonsteroidal Anti-inflammatory Drug Combination Therapy and Renal Function in Gout Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: En Chu Kong Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 100 Years
• Healthy volunteers: Accepted

Summary

Our findings are expected to provide real-world evidence of the renal-adverse effects of colchicine and NSAIDs combination therapy in patients with gout, which will guide healthcare professions in optimizing gout treatment regimens and evaluating risks of renal impairment.

Detailed description

Background: Gout is a common prevalent disease, which causes a low quality of life and poses a significant health burden nationally and internationally. Colchicine and Nonsteroidal anti-inflammatory drug (NSAID) are the mainstay treatment of gout. Concurrent use of colchicine and NSAIDs are more than half in all prescriptions of the gout patients. Both colchicine and NSAIDs may cause renal impairment. However, the empirical evidence of renal impairment of colchicine and NSAIDs combination therapy is limited and even absent. Objectives: This proposal will assess the association between colchicine and NSAIDs combination therapy and acute kidney injury. The investigators further evaluate the relationships of duration-response, recency-response, and dose-response.

Conditions

• Renal Impairment
• Gout
• Colchicine Adverse Reaction
• Nonsteroidals (NSAIDs)Toxicity

Interventions

Type	Name	Description
DRUG	Colchicine and NSAID	Colchicine and nonsteroidal anti-inflammatory drug combination therapy

Timeline

• Start date: 2012-01-01
• Primary completion: 2019-12-31
• Completion: 2024-12-31
• First posted: 2021-08-16
• Last updated: 2021-08-16

Regulatory

• FDA-regulated drug study